May I begin by telling you that no one who has written about me or broadcast
information about me has ever interviewed me. The information being disseminated is rumor and innuendo. I am pro-life and believe in the sanctity of human life.
I participated in the Citizens Petition to the FDA asking that RU-486 be withdrawn
temporarily from the market until further investigation could be done out of my concern for the health and well-being of women
and their unborn children. Mifeprex was approved under an Accelerated Approval Process, Subpart H, that has been reserved
exclusively for anti-AIDS and anti-cancer drugs and an antihypertensive agent. All medications that are life saving,
which mifeprex is not. The FDA always requires one or more than one randomized, controlled trials before approving a
drug. There were none for mifeprex (RU-486). The nonrandomized, uncontrolled trials that were done insisted on
the woman having an ultrasound scan to locate the pregnancy and insure that it was not outside the uterus (an ectopic pregnancy).
The guidelines for use now do not require such a scan and we have reports already of death and morbidity from ruptured ectopic
pregnancies since the symptoms of a ruptured ectopic and abortion from mifeprex are the same; abdominal pain and bleeding.
The FDA requires that medications that may be used in children and adolescents be studied in those groups before approval
(The Pediatric Rule) and this was not done with mifeprex. There have been two seriously infected 15 year olds.
Finally, in studies reported to date, among women who fail to abort after receiving mifeprex (and this occurs 5-8% of the
time when administered up to 7 weeks gestation) there have been limb deformities and absent limbs. I feel that the drug
needs further study. Searle Laboratories, the manufacturer of misoprostol (the second drug taken after mifepristone)
has issued a medical alert asking that the drug never be used in pregnant women due to risks of cardiovascular problems.
There has been a fatal heart attack in France and a non-fatal one here in a 21 year old.
Regarding contraception, I advise all of my non-married patients that abstinence
is the best way to avoid non-marital pregnancy and STDs. If she insists on being sexually active or is already active,
I advise the use of birth control pills and condoms as well. I do not believe that standard dose birth control pills are abortifacient,
and have never written that. There is a chapter in a book I co-edited, that purports this idea, but it was included
in our book to offer an alternative opinion, not because we believed the idea. Since when is it wrong to offer alternative
Regarding my management and writing about stress-related disorders in women, I have
always offered a holistic approach to therapy. I suggest diet/exercise changes, medications as needed, counseling when
required, and meditation/prayer. This is very distasteful to NOW and Planned Parenthood.
I hope this helps you and
enables you to see how "horrible" I am in the eyes of the organizations you mention as encouraging me not to serve this Administration.
David Hager, M.D.